This purpose of this study is to assess the safety of ramelteon, once daily (QD), in subjects with chronic obstructive pulmonary disease.

Detailed Description

Insomnia is characterized by difficulties initiating and maintaining sleep, or complaints of non-restorative and non-refreshing sleep. Transient insomnia affects approximately one-third to one-half of the US population, based on the results of 2 surveys of representative samples of the adult US population conducted by the Gallup Organization in which respondents were asked if they had "ever had difficulty sleeping." Based on reports of "regular" or "frequent" sleep difficulty, results from the same studies suggest that approximately one-tenth of the US population experiences chronic insomnia. The ideal treatment for insomnia would reduce the latency to onset of sleep and increase total sleep time, without a negative impact on sleep architecture and without safety concerns or next-day effects.

Ramelteon is under global development by Takeda Chemical Industries, Ltd., for the treatment of transient and chronic insomnia and for the treatment of Circadian Rhythm Sleep Disorders.

This study is being conducted to assess the safety of ramelteon in subjects with chronic obstructive pulmonary disease. Participation in the study is anticipated to be about 1.5 months.

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

26

Completion Date

March 2004

Primary Completion Date

March 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria

Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

Clinical history of chronic obstructive pulmonary disease and a confirmatory diagnosis based on pulmonary function tests at screening.

Moderate: forced expiratory volume in one second/ forced vital capacity less than 70% and forced expiratory volume 135-75% of predicted.

Post-bronchodilator forced expiratory volume in one second change from baseline of less than 12%.

Negative chest x-ray at screening, other than findings consistent with mild to moderate chronic obstructive pulmonary disease, within the last 6 months.

Arterial oxygen saturation during sleep greater than 85% for at least 99% of the recording period, with no arterial oxygen saturation readings less than 80% as assessed by pulse oximetry at polysomnography screening.

Arterial oxygen saturation during wakefulness greater than 91% (both supine and sitting) as assessed by pulse oximetry at screening.

Habitual bedtime is between 8:30 p.m. and 12:00 a.m.

Body mass index between 18 and 34, inclusive.

Agrees to remain in the study center for three overnight stays.

Exclusion Criteria:

Known hypersensitivity to ramelteon or related compounds, including melatonin.

Known hypersensitivity to Ventolin® or related compounds.

Previously participated in a study involving ramelteon.

Participated in any other investigational study and/or taken any investigational drug within 30 days or five half-lives prior to Day 1 of study medication, whichever is longer.

History of alcohol abuse within the past 12 months and/or regularly consumes 4 or more alcoholic drinks per day.

Unable to discontinue the use of hypnotics for the duration of the study.

Any clinically important abnormal finding, other than chronic obstructive pulmonary disease, as determined by medical history, physical examination, electrocardiogram, or clinical laboratory tests, as determined by the investigator.

Current significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease, unless currently controlled and stable with protocol-allowed medication 30 days prior to Day 1 of study medication.

Hematocrit value greater than 55% at screening.

Positive hepatitis panel.

Any additional condition(s) that in the Investigator's opinion would:

affect sleep-wake function

prohibit the subject from completing the study

not be in the best interest of the subject

Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication, including:

Anxiolytics

Hypnotics

Antidepressants

Anticonvulsants

Sedating H1 antihistamines

Systemic steroids

Decongestants

Over-the-counter and prescription stimulants

Over-the-counter and prescription diet aids

Central nervous system active drugs and narcotic analgesics

Lipophilic beta blockers

Melatonin

St. John's Wort

Kava-kava

Gingko biloba

Gender

Both

Ages

21 Years and older (Adult, Senior)

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects